CAMBRIDGE, England,
February 12, 2016 /PRNewswire/ --
In a clinical trial,
relapsed patients treated with carfilzomib
in combination with lenalidomide and
dexamethasone lived 8.7 months longer without
disease progression compared with lenalidomide and
dexamethasone alone
Amgen today announced that Kyprolis® (carfilzomib) in
combination with lenalidomide and dexamethasone is now available in
the UK for the treatment of adult patients with multiple myeloma
who have received at least one prior therapy. Carfilzomib is the
first licensed irreversible proteasome inhibitor for use in
combination treatment of patients with relapsed multiple
myeloma.[1]
(Logo:
http://photos.prnewswire.com/prnh/20160211/332333LOGO )
The European Commission licensed carfilzomib in combination with
lenalidomide and dexamethasone based on the ASPIRE study in
November 2015. Carfilzomib has shown
significant improvement in progression-free survival (PFS) compared
to lenalidomide and dexamethasone, reinforcing the belief that it
may provide a new treatment option for patients with relapsed
multiple myeloma.
"Multiple myeloma is a rare and aggressive blood cancer that
often becomes resistant to treatment, which is why there is a need
for new therapeutic options that extend the time patients live
without their disease progressing," said Tony Patrikios, Executive Medical Director at
Amgen UK.
He added, "Although advances in treatment have been made over
recent decades, multiple myeloma remains an incurable disease. We
deeply appreciate the commitment of patients in over 20 UK clinical
centres who have participated in clinical trials that has allowed
us to bring carfilzomib to patients in the UK. Carfilzomib provides
an important new treatment option for relapsed multiple myeloma,
helping to address a real unmet need for this rare blood cancer. We
will continue to work with all our partners and stakeholders to
ensure this new medicine is made available to patients in the
UK."
Myeloma UK Chief Executive Eric
Low said, "Myeloma is a relapsing and remitting cancer and
so it's extremely important that we continue to see access to new
effective treatments. To that end, we very much welcome the
European approval of carfilzomib and we will work closely with
Amgen and the various healthcare technology assessment bodies in
the UK to ensure that patients get access as quickly as
possible."
Amgen expects to make a submission to the National Institute for
Health and Care Excellence later in 2016 based on the ASPIRE study,
already reflected in the current labelling for carfilzomib, and
also the ENDEAVOR study.
In the pivotal Phase 3 ASPIRE (CArfilzomib, Lenalidomide,
and DexamethSone versus Lenalidomide and Dexamethasone for
the treatment of PatIents with Relapsed
Multiple MyEloma) study, patients with relapsed/refractory
multiple myeloma (RRMM) treated with carfilzomib in combination
with lenalidomide and dexamethasone achieved more than two years
without disease progression. Of these approximately one out of
three patients achieved a complete response or
better.[2] These results indicate
that carfilzomib is a step forward in the treatment of patients
with multiple myeloma.
Complete response in the study was defined as treatment outcomes
where there are less than 5 percent plasma cells in the bone marrow
and no evidence of myeloma proteins in the serum or urine as
measured by standard laboratory
techniques.[2]
In the ASPIRE study, carfilzomib in combination with
lenalidomide and dexamethasone (regimen referred to as KRd)
increased median time to progressive disease or death by 8.7 months
compared to patients treated with lenalidomide and dexamethasone
(regimen referred to as Rd).[2]
The median PFS was 26.3 months in the KRd arm compared to 17.6
months in the Rd arm (HR: 0.69; 95%CI: 0.57 to 0.83;
P=0.0001).[2] In a pre-planned
post-hoc analysis of PFS, patients who received KRd early in their
treatment pathway (at 1st relapse) showed a more
pronounced benefit with 12 months additional PFS (29.6 months
compared with 17.6 months for Rd alone, HR 0.69
(0.52-0.94).[3]
Discontinuation of treatment due to adverse events occurred in
15 percent of patients in the KRd arm versus 18 percent of patients
in the Rd arm.[2] In clinical
trials with carfilzomib, the most common adverse reactions
(occurring in more than 20 percent of patients) were anaemia,
fatigue, diarrhoea, thrombocytopenia, nausea, pyrexia, dyspnoea,
respiratory tract infection, cough and peripheral
oedema.[1] Cases of hepatic
failure (less than one percent) were also reported by patients in
clinical studies with
carfilzomib.[1]
The Phase 3 ENDEAVOR (RandomizEd, OpeN Label,
Phase 3 Study of Carfilzomib Plus DExamethAsone
Vs Bortezomib Plus DexamethasOne in Patients With
Relapsed Multiple Myeloma) trial compared PFS in patients
with multiple myeloma treated with carfilzomib plus dexamethasone
versus those receiving Velcade® (bortezomib) plus
dexamethasone.[4] The data from
this study are currently being reviewed by the European Medicines
Agency.
Although multiple myeloma is not as widely known as other types
of cancer, it is the second most common haematological cancer in
the UK,[5] characterised by
unregulated plasma cell proliferation. With approximately 4,900 new
cases diagnosed each year,[6] the
UK incidence rate is ninth highest in Europe for males and eighth highest for
females.[6] It is estimated that
around 15,000-20,000 people are living with myeloma in the
UK.[7] Multiple myeloma is an
aggressive cancer with less than half of patients surviving for
five years,[8] leading to more
than 2,700 deaths in the UK in
2012.[9]
About Kyprolis® (carfilzomib)
for Injection
Carfilzomib is an irreversible proteasome inhibitor for use in
the treatment of patients with relapsed multiple
myeloma.[3] Proteasomes play an
important role in cell function and growth by breaking down
proteins that are damaged or no longer
needed.[10] Carfilzomib has
been shown to block proteasomes, leading to an excessive build-up
of proteins within
cells.[1] In some cells,
carfilzomib can cause cell death, especially in myeloma cells
because they are more likely to contain a higher amount of abnormal
proteins.[1] The
irreversibility of carfilzomib's binding has also been shown to
offer sustained inhibition of the targeted
enzymes.[11]
Important EU Product Safety Information for
Carfilzomib
▼ This medicinal product is subject to additional
monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions.
Carfilzomib treatment should be supervised by a physician
experienced in the use of anti-cancer therapy. The most serious
side effects that may occur during carfilzomib treatment include
cardiac toxicity, pulmonary toxicities, pulmonary hypertension,
dyspnoea, hypertension including hypertensive crises, acute renal
failure, tumour lysis syndrome, infusion reactions,
thrombocytopenia, hepatic toxicity, posterior reversible
encephalopathy syndrome (PRES) and thrombotic thrombocytopenic
purpura/haemolytic uremic syndrome (TTP/HUS).
Please refer to the Summary of Product Characteristics for full
European prescribing information:
https://www.medicines.org.uk/emc/medicine/31222.
About Amgen
Amgen is committed to unlocking the potential of biology
for patients suffering from serious illnesses by discovering,
developing, manufacturing and delivering innovative human
therapeutics. This approach begins by using tools like advanced
human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its biologics manufacturing expertise to strive for
solutions that improve health outcomes and dramatically improve
people's lives. A biotechnology pioneer since
1980, Amgen has grown to be one of the world's leading
independent biotechnology companies, has reached millions of
patients around the world and is developing a pipeline of medicines
with breakaway potential.
For more information, visit http://www.amgen.co.uk and
follow us on http://www.twitter.com/amgen.
References:
- Kyprolis® (carfilzomib). Summary of Product
Characteristics. November 19, 2015.
Available at https://www.medicines.org.uk/emc/medicine/31222
[accessed 04 Feb 2016]
- Stewart KA, Rajkumar VS, Dimopoulos MA, et al. Carfilzomib,
Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma. N
Engl J Med. 2015; 372:142-152.
- Dimopoulos, MA, Stewart KA, Rajkumar VS, et al. Effect of
Carfilzomib, Lenalidomide, and Dexamethasone vs Lenalidomide and
Dexamethasone in Patients With Relapsed Multiple Myeloma by Line of
Therapy: Secondary Analysis From an Interim Analysis of the Phase 3
Study ASPIRE (NCT 01080391). Poster 342 presented American Society
of Clinical Oncology, May 29 - June 2,
2015; Chicago,
Illinois.
- Clinicaltrials.gov: Phase 3 Study With Carfilzomib and
Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed
Multiple Myeloma Patients (ENDEAVOR). Available at
https://clinicaltrials.gov/ct2/show/NCT01568866 [accessed
09 Feb 2016]
- Cancer Research UK. Cancer incidence for common cancers.
Available at
http://www.cancerresearchuk.org/health-professional/cancer-statistics/incidence/common-cancers-compared#heading-Zero
[accessed 11 Feb 2016]
- Cancer Research UK. Myeloma statistics. Available at
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma#heading-Zero
[accessed 11 Jan 2016]
- Myeloma UK - Myeloma: Essential Guide. Available at:
http://www.myeloma.org.uk/wp-content/uploads/2013/09/Myeloma-UK-Living-well-with-myeloma-Essential-Guide-Nov-2015.pdf
[accessed 12 Jan 2016]
- Seer. Available at
http://seer.cancer.gov/statfacts/html/mulmy.html [accessed
11 Jan 2016]
- Cancer Research UK. Myeloma mortality statistics. Available at
http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/myeloma/mortality#heading-Zero
[accessed 11 Jan 2016]
- Moreau P, Richardson PG, Cavo M. et al. Proteasome Inhibitors
in Multiple Myeloma: 10 Years Later. Blood. 2012;
120(5):947-959.
- Kortuem KM and Stewart AK. Carfilzomib. Blood. 2012;
121(6):893-897.
Job number: UKIE-CC-CARF-0116-123303
Date of preparation: February
2016